Eli Lilly is fronting some new cash in a space they’re quite familiar with.
The company is partnering with Japan’s Asahi Kasei Pharma on an experimental drug for chronic pain, acquiring the rights for the P2X7 receptor antagonist program dubbed AK1780. Lilly will shell out a pretty penny for the program, promising up to $410 million total should each milestone payment come to pass.
Asahi Kasei will receive an upfront sum of $20 million for the candidate. In addition, Lilly is on the hook for up to $210 million in development and regulatory milestones and another potential $180 million in sales milestones. Asahi Kasei can also obtain royalties ranging from the mid-single to low-double digits should an approved product come out of the deal.
AK1780 recently completed Phase I single and multiple ascending doses and clinical pharmacology studies, Asahi Kasei said Thursday. Lilly’s immediate plans for the program are unclear, and we’ve sent out a request for comment.
The P2X7 receptor that’s the target of this deal comes from a family of purinoceptors that are activated by ATP. P2X7 specifically is activated only by high concentrations of ATP and is thought to play a role in cell death and inflammation, as well as inflammatory bowel disease, neurodegenerative diseases, mood disorders and cancers.
Some other receptors in the group, such as P2X3, are activated at lower concentrations and can pop up in diseases caused by abnormal neural transmissions. P2X-related programs saw significant investment in the early 2000s, according to
Nature
, but poor efficacy results in clinical trials, particularly in rheumatoid arthritis. One major player backed off around this time, with Roche axed a P2X3 candidate.
Pain programs are nothing new for Lilly, which currently has tanezumab before the FDA for osteoarthritic pain. Lilly collaborated with Pfizer on the candidate and its expected PDUFA date had been last December, but no decision has been reached just yet.
The tanezumab ruling could have implications on the anti-NGF class of pain drugs. Nearly a decade ago, the field was crushed by safety issues and began a long, slow return to late-stage testing. Lilly and Pfizer are hoping to turn the fortunes around, but
poor Phase III safety data
revealed in early 2019 had analysts running for the hills.
Despite the grim outlook, the pair decided to push forward anyway to see if they can squeeze past the FDA with the low-dose version of tanezumab. A rival therapy from Regeneron and Teva was also given long odds after
posting Phase III data
last August, and Regeneron chief Len Schleifer told
Endpoints News
at the time that the company will be paying close attention to the FDA’s ruling on tanezumab.
